ALESSANDRA FERNANDES BACCARO
Projetos de Pesquisa
Unidades Organizacionais
LIM/51 - Laboratório de Emergências Clínicas, Hospital das Clínicas, Faculdade de Medicina
3 resultados
Resultados de Busca
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- Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial - SELECT TDCS: Design, rationale and objectives(2011) BRUNONI, Andre Russowsky; VALIENGO, Leandro; BACCARO, Alessandra; ZANAO, Tamires Araujo; OLIVEIRA, Janaina Farias de; VIEIRA, Giselly Pereira; BUENO, Viviane Freire; GOULART, Alessandra C.; BOGGIO, Paulo Sergio; LOTUFO, Paulo Andrade; BENSENOR, Isabela Martins; FREGNI, FelipeBackground: Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with tools of non-invasive brain stimulation - such as transcranial magnetic stimulation and transcranial direct current stimulation (tDCS). Due to its profile, tDCS seems to be a safe and affordable approach. Methods and design: The SELECT TDCS trial aims to compare sertraline vs. tDCS in a double-blinded, randomized, factorial trial enrolling 120 participants to be allocated to four groups to receive sertraline + tDCS, sertraline, tDCS or placebo. Eligibility criteria are moderate-to-severe unipolar depression (Hamilton Depression Rating Scale >17) not currently on sertraline treatment. Treatment will last 6 weeks and the primary outcome is depression change in the Montgomery-Asberg Depression Rating Score (MADRS). Potential biological markers that mediate response, such as BDNF serum levels, Val66Met BDNF polymorphism, and heart rate variability will also be examined. A neuropsychological battery with a focus on executive functioning will be administered. Discussion: With this design we will be able to investigate whether tDCS is more effective than placebo in a sample of patients free of antidepressants and in addition, we will be able to secondarily compare the effect sizes of sertraline vs. tDCS and also the comparison between tDCS and combination of tDCS and sertraline.
- The Sertraline vs Electrical Current Therapy for Treating Depression Clinical Study Results From a Factorial, Randomized, Controlled Trial(2013) BRUNONI, Andre R.; VALIENGO, Leandro; BACCARO, Alessandra; ZANAO, Tamires A.; OLIVEIRA, Janaina F. de; GOULART, Alessandra; BOGGIO, Paulo S.; LOTUFO, Paulo A.; BENSENOR, Isabela M.; FREGNI, FelipeImportance: Transcranial direct current stimulation (tDCS) trials for major depressive disorder (MDD) have shown positive but mixed results. Objective: To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment (sertraline hydrochloride, 50 mg/d). Design: Double-blind, controlled trial. Participants were randomized using a 2 x 2 factorial design to sertraline/placebo and active/sham tDCS. Setting: Outpatient, single-center academic setting in Sao Paulo, Brazil. Participants: One hundred twenty antidepressant free patients with moderate to severe, nonpsychotic, unipolar MDD. Interventions: Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS (twelve 30-minute sessions: 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week) and sertraline hydrochloride (50 mg/d). Main Outcome Measures: In this intention-to-treat analysis, the primary outcome measure was the change in Montgomery-Asberg Depression Rating Scale score at 6 weeks (end point). We considered a difference of at least 3 points to be clinically relevant. The analysis plan was previously published. Safety was measured with an adverse effects questionnaire, the Young Mania Rating Scale, and cognitive assessment. Secondary measures were rates of clinical response and remission and scores on other scales. Results: At the main end point, there was a significant difference in Montgomery-Asberg Depression Rating Scale scores when comparing the combined treatment group (sertraline/active tDCS) vs sertraline only (mean difference, 8.5 points; 95% CI, 2.96 to 14.03; P = .002), tDCS only (mean difference, 5.9 points; 95% CI, 0.36 to 11.43; P = .03), and placebo/sham tDCS (mean difference, 11.5 points; 95% CI, 6.03 to 17.10; P < .001). Analysis of tDCS only vs sertraline only presented comparable efficacies (mean difference, 2.6 points; 95% CI, -2.90 to 8.13; P = .35). Use of tDCS only (but not sertraline only) was superior to placebo/sham tDCS. Common adverse effects did not differ between interventions, except for skin redness on the scalp in active tDCS (P = .03). There were 7 episodes of treatment-emergent mania or hypomania, 5 occurring in the combined treatment group. Conclusions and Relevance: In MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ.
conferenceObject Sertraline vs. Electrical Current Therapy for Treating Depression Clinical Trial (SELECT TDCS): Results from a Factorial, Randomized, Controlled Trial(2012) BRUNONI, Andre; VALIENGO, Leandro; BACCARO, Alessandra; ZANAO, Tamires; OLIVEIRA, Janaina Farias de; GOULART, Alessandra; LOTUFO, Paulo; BOGGLE, Paulo; BENSENOR, Isabela; FREGNI, FelipeBackground: Non-invasive brain stimulation has been increasingly used as an intervention for major depressive disorder (MDD). Methods: Randomized, factorial, double-blinded, controlled trial. Participants were randomized to sertraline/placebo and active/sham tDCS. They presented moderate to severe medication-free, nonpsychotic, unipolar, major depressivedisorder. They received 6-week treatment of 2mA anodal left dorsolateral prefrontal tDCS (twelve 30-min sessions: 10 consecutive sessions plus two extra sessions every other week) and sertraline (50mg/day). The primary outcome was the Montgomery-Asberg depression scale (MADRS) score changes at the end of treatment (6-week). A difference of at least 3 points in scores was consideredclinically relevant. Secondary outcomes were remission and response rates, and other depression scales. Results : At six weeks (primary outcome), the combined treatment was superior to sham tDCS - placebo (mean difference= 11.5 points; 95% CI=6.03 to 17.1; p<0.01) to sham tDCS -sertraline (mean 8.5; 95% CI=2.96 to 14.03; p<0.01) and to active tDCS - placebo (mean 5.9; 95%=CI 0.36 to 11.43). TDCS and sertraline alone were not different between each other (mean 2.6; 95% CI=8.13 to -2.9; p=0.35). Secondary efficacy analyses mainly confirmed these findings. Adverse effects were not significantly different when comparing groups, althoughfive of seven episodes of treatment-emergent (hypo)mania were observed in the combined treatment. Conclusions: In MDD, combination of tDCS and sertraline increases the efficacy of each treatment alone. Efficacy/safety did not differ between them.